A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Advocacy, Ethics, & PP Advocacy, Ethics, and the Precautionary Principle NAHMMA's 2005 Conference September 18-23, 2005 Tacoma, Washington Steven G. Gilbert, PhD, DABT LINKLINK

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 NW Public Health See: nwph Public Health and the Precautionary Principle By Steven G. Gilbert

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Child Health

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Doubt / Uncertainty "Doubt is our product since it is the best means of competing with the 'body of fact' that exists in the mind of the general public.“ 1969 an executive at Brown & Williamson owned by R. J. Reynolds Tobacco Company (Doubt Is Their Product by David Michaels in Scientific American, June 15, 2005)

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Vision of Child Health Knowledge of Reproductive and Developmental Toxicology Policy Approach within an ethical framework Social responsibilities No technical solutions Restriction of freedoms Precautionary Principle Convergence of Issues

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 American Academy of Pediatrics Mission and vision To attain optimal physical, mental and social health and well-being for all infants, children, adolescents and young adults.

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 American Academy of Pediatrics The APA goes on to state: “To this purpose, the AAP and its members dedicate their efforts and resources. The vision: 1) to advocate for infants, children, adolescents, and young adults and provide for their care; 2) to collaborate with others to assure child health; and ….

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 “Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.” S. Gilbert (1999) Environmental & Human Health

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 The challenge To develop an individual and societal ethical framework for decision making that supports the long term maintenance of a globally sustainable ecology Ecological Bioethics

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Socially responsible white guys?

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 "All scientific work is incomplete - whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. That does not confer upon us a freedom to ignore the knowledge we already have or postpone the action that it appears to demand at a given time. " Sir Austin Bradford Hill (1965) Sir Austin Bradford Hill

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 1.Strength of association 2.Consistency of findings 3.Biological gradient 4.Temporal sequence 5.Biologic or theoretical plausibility 6.Coherence with established knowledge 7.Specificity of association Sir Austin Bradford Hill (1965) Determining Causation

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Statistical Model Fundamental Types of Uncertainty

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Easiest to examine & reduce Not knowing the exact value of a variable (inter and intra subject variance) Sample size Statistical Uncertainty Reducing Variability

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Not fully understanding the relations between variables (mechanism of action) Which variables are most important (high dose vs low dose) Model or System Uncertainty

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Not knowing the right questions to ask Most sensitive end point “we don’t know what we don’t know” Fundamental Uncertainty

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead In Homes

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in Families

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 "Lead makes the mind give way." Ancient Awareness Greek Dioscerides - 2nd BC

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead Based Paint Products

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead Based Paint US medical authorities diagnose childhood lead poisoning Child lead poisoning linked to lead-based paints France, Belgium and Austria ban white-lead interior paint Pediatric lead-paint poisoning death from eating crib paint is described National Lead Company admits lead is a poison League of Nations bans white-lead interior paint; US declines to adopt Report concludes eating lead paint chips causes physical and neurological disorders, behavior, learning and intelligence problems in children Lead-Based Paint Poisoning Prevention Act passed

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead Industry Advertisements History of Lead Industry Advertisements (LINK)LINK

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Agency Blood Lead Levels

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 California Suing Major Retailers Over Lead in Jewelry Allegations California is suing 13 major retailers alleging they broke state law by not warning customers that some of their jewelry contains lead. Private lawsuits containing similar allegations have been filed against a further 11 retailers. Named in the state's suit were Macy's, Target, Wal- Mart, Kmart, J.C. Penney, Mervyn's, Nordstrom, Ross, Sears, Express, Claire's, Toys "R" Us and Burlington Coat Factory, along with some of their affiliates and parent companies, according to The San Jose Mercury News. (June 24, 2004) Lead in Jewelry

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in Jewelry

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Children & Candy & Lead Data from WA DOH (

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 WA State Guidelines The Washington State Department of Health advises consumers not to eat candy from Mexico or southeast Asia that contains tamarind or chili powder. ( California also has documented lead in candy. See the Orange County Register series on lead in candy:

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in WA Candy Data from WA DOH (

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in Pottery – Action Levels US Food and Drug Administration (FDA) action levels for the lead content of the leachate: Cups, mugs, and pitchers: 0.5 ppm Large hollowware (serving dishes): 1 ppm Small hollowware (bowls): 2 ppm Plates, saucers, and other flatware: 3 ppm

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead in WA Pottery Data from WA DOH (

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Pottery with Lead Data from WA DOH (

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead & Lunchboxes The Center for Environmental Health (CEH)

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead In Ethnic Remedies RemedyUseLead Content Azarcon (Mexico) Digestive problems 76-86% Greta (Mexico) Digestive problems 4-90% Surma (India) Cosmetic to improve eye sight 23-26% Tibet Improve slow development 1-3%

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Policy Implications Drinking water in Seattle Schools

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Children in WA State Blood Lead No.% (mcg/dL) 0-19, , , Children 0-6 tested in WA State DOH

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Children with >10 mcg/dL In 1999 and 2000, 2.2% of children 1-5 year age had lead levels that were above 10 mcg/dL. Approximately 20 million children under age 5, thus about 440,000 children in the US have blood lead levels above 10 mcg/dL. From CDC

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 A Small Dose of …. Health Effects (< 10 mcg/dL)

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Needleman, NEJM, 1979

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Consequences for Society (Slide from B. Weiss)

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead-associated Reading Deficits in U.S. Children Blood lead levels (  g/dl) Reading Score Lanphear BP, et al. Public Health Reports 2000;115: (BL’s slide)

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Canfield R, et al. NEJM 2003;348: IQ and Blood Lead Life time overall Increase in 1 mcg/dl = 0.87 IQ drop Covariates - 1 mcg/dl = 0.46 IQ drop 1 to 10 mcg/dl (bigger drop) Increase in 1 mcg/dl = 1.37 IQ drop Non-linear - 1 mcg/dl = 7.4 IQ drop

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Canfield R, et al. NEJM 2003;348: (slide from BL) IQ and Blood Lead

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 The challenge “the knowledge of how to use knowledge for the social good” Knowledgeable Bioethics

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 “When an activity raises threats of harm to human health or the environment, precautionary measures should be take even if some cause and effect relationships are not fully established scientifically.” Wingspread Conference, Precautionary Principle

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05  FDA regulations of Drugs (1938)  FDA regulations of Dietary Supplements (Dietary Supplement Health and Education Act of 1994 (DSHEA))  Ephedra present an unreasonable risk of illness or injury (Dec, 2003) Safety & Efficacy vs Harm

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Taking preventive action in the face of uncertainty Shifting the burden of proof/responsibility to the proponents of an activity Exploring a wide range of alternatives to possibly harmful actions Increasing public participation in decision making (environmental justice) Wingspread Conference, Central components

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 City Comprehensive Plans Every citizen of Seattle has an equal right to a healthy and safe environment. Seattle sees the Precautionary Principle approach as its policy framework to develop laws for a healthier and more just Seattle. Seattle PP working group Seattle Initiative

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Seattle Precautionary Principle White Paper ( Inclusion of PP in Comp Plan Environment Element ( ehensive_Plan/DPD_ asp) LinkLink Result of Effort

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 “Protecting Public Health by Adopting the Precautionary Principle as an Approach to Decision Making” Resolution Submitted to Washington State Public Health Association WSPHA Resolution

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05  California San Francisco Precautionary Purchasing Ordinance - June 2005 Resolution of the Marin county board of supervisors “A resolution to continue to incorporate the precautionary principle in county operations.” Oct 2004  Oregon Multnomah County, OR Resolution - September 2004  New York State Legislation - April 2005  Bill A07256 “To protect public health and the environment by establishing a precautionary policy for state and local governments in New York State.”  Bill A07257 “To establish a preference for the purchase of commodities, services, and technologies by the State of New York that minimize potential adverse impacts on public health and the environment.” States in the US

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Agreement Respecting Canada-wide Standards for Dioxins and Furans: Steel Manufacturing Electric Arc Furnaces Pollution Prevention Strategy “In keeping with the Precautionary Principle as set out as guidance in the Canada-wide Standards Sub-agreement, and in consideration of the CWS principles of sound science, technical feasibility and socio-economic impacts, …..” Canada and PP

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 REACH -- Registration, Evaluation and Authorization of Chemicals  The two most important aims are to improve protection of human health and the environment from the hazards of chemicals and enhance the competitiveness of the EU chemicals industry.  The Commission’s White Paper on the Strategy for a future Chemicals Policy was adopted in on 13 February  A Precautionary approach REACH-European Union

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 REACH -- Registration, Evaluation and Authorization of Chemicals  Initially regulate High Production Volume (HPV) chemicals - produced or imported above 1,000 metric tons.  Total world wide production of chemicals 400 million metric tons per year or $1.6 Trillion  To be introduced into European Parliament late this year. REACH

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 The citizen toxicologist is a thoughtful advocate for human and environmental health, who strives to share their scientific knowledge with the public, speaking to public interests rather than private or special interests. Citizen Toxicologist Socially Responsible Toxicologist

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Testifying Writing review papers K-12 class room teaching Adding expertise to community groups Education Mentoring Speakers Bureau Socially Responsible Actions

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Forum in which to discuss the ethical implications of results from our science as well as the resulting legal and social implications SOT meeting – workshop on Conflict of Interest SOT - ELSI Specialty Section

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Children have a right to a safe, fair and healthy environment Ethical Responsibility to share and use of knowledge Duty to promote health and well being of children Thoughtful public health advocate Knowledge - Responsibility

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Additional Information  The Science and Environmental Health Network (SEHN) (  Late lessons from early warnings: the precautionary principle – European Environment Agency (free)  Garrett Hardin - The Tragedy of the Commons (Science, 1968)  Ethics and Environmental Health – Mini Monograph - Environmental Health Perspectives (November 2003)  Ethical, legal, and social issues: our children's future. Steven G. Gilbert. Neurotoxicology, 26/4 pp ,  Public Health and the Precautionary Principle. Steven G. Gilbert. NW Public Health, Spring

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Scientific Process Variability Uncertainty

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Statistical Model Fundamental Types of Uncertainty

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Easiest to examine & reduce Not knowing the exact value of a variable (inter and intra subject variance) Sample size Statistical Uncertainty Reducing Variability

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Not fully understanding the relations between variables (mechanism of action) Which variables are most important (high dose vs low dose) Model or System Uncertainty

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Not knowing the right questions to ask Most sensitive end point “we don’t know what we don’t know” Fundamental Uncertainty

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Dose Response Issues Higher metabolic rate Different nutritional requirements Rapidly dividing & migrating cells Immature organs Susceptibility of Children

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Ethics and the Precautionary Principle Questions or Comments? Download Presentation from

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Authorship Information For Additional Information Contact Steven G. Gilbert, PhD, DABT Web: This presentation is supplement to “A Small Dose of Toxicology”

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Socially Responsible

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Recycling Lead

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 “Conclusions: Blood lead concentrations, even those below 10 mgc/dL, are inversely associated with children’s IQ scores at three and five years of age, and associated declines in IQ are greater at these concentrations than at higher concentrations. These findings suggest that more U.S. children may be adversely affected by environmental lead than previously estimated.” Canfield et al. 2003, NEJM, 384 Canfield et al…, 2003

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Agency Blood Lead Levels

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Environmental Pollutants and Disease in American Children: Estimates of Morbidity, and Costs for Lead Poisoning, Asthma, Cancer, and Developmental Disabilities, by Landrigan, P. et al. EHP, 110, July 2002, Cost of Childhood Lead Assumptions in calculating costs All lead is harmful and from environment Blood lead of children age 5 – 2.7 ug/dl (CDC) 5-year old boys (1,960,200) and girls (1,869,800) 1 ug/dl of lead = 0.25 IQ point reduction Cost – boys $27.8 and girls $15.6 Billion Total Costs $43.4 Billion

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Stephen J. Rothenberg and Jesse C. Rothenberg, Testing the Dose-Response Specification in Epidemiology: Public Health and Policy Consequences for Lead Environ Health Perspect 113: (2005) Policy Consequences of Lead “The Centers for Disease Control and Prevention action limit of 10 µg/dL for children fails to protect against most damage and economic cost attributable to lead exposure.”

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 A Small Dose of …. Regulation (CDC Guidelines)

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Current CDC Policy Blood lead level µg/dL) b Actions Time frame for beginning intervention 10-14Provide caregiver lead education. Provide follow-up testing. Refer the child for social services if necessary. Within 30 days 15-19Above actions, plus: If BLLs persist (i.e., 2 venous BLLs in this range at least 3 months apart) or increase, proceed according to actions for BLLs Within 2 weeks 20-44Above actions, plus: Provide coordination of care (case management). Provide clinical evaluation and care. c Provide environmental investigation and control current lead hazards. Within 1 week 45-70Above actions.Within 48 hours 70 or higherAbove actions, plus hospitalize child for chelation therapy immediately. Within 24 hours

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Proposed CDC Policy Blood lead level (µg/dL) ActionsTime frame for beginning intervention <2No action 2-5Provide caregiver lead education. Provide follow-up testing. Refer the child for social services to investigate possible sources of lead exposure. Within 30 days 5-10Above actions, plus:If BLLs persist (i.e., 2 venous BLLs in this range at least 3 months apart) or increase, proceed according to actions for BLLs Within 2 weeks 10-20Above actions, plus: Provide coordination of care (case management). Provide clinical evaluation and care. Provide environmental investigation and control current lead hazards. Within 1 week 20-70Above actions.Within 24 hours 70 or higherAbove actions, plus hospitalize child for chelation therapy immediately. Within 24 hours

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Policy Implications An Ethical and Precautionary Approach to Protecting Our Children Drinking water in Seattle Schools

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Agency Blood Lead Levels

A Small Dose of ToxicologyNAHMMA – Advocacy.PP 9/22/05 Lead 10 to 2 Campaign Steven G. Gilbert